HIV Testing Strategies in the Perinatal Setting

NCT00503308

Last updated date
Study Location
UCSF, San Francisco General Hospital
San Francisco, California, 94110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections, Pregnancy Related
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women 16 years of age or above seeking prenatal care at San Francisco General Hospital

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Women who do not speak Spanish or English


- Women younger than 16 years of age


- Women who obtained an HIV test during the index pregnancy prior to initiation of
prenatal care at SFGH


- Women known to be infected with HIV at initiation of prenatal care at SFGH

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HIV Infections, Pregnancy RelatedHIV Testing Strategies in the Perinatal Setting
NCT00503308
  1. San Francisco, California
Female
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE HIV Testing Strategies in the Perinatal Setting
Official Title  ICMJE Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
Brief Summary The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).
Detailed Description

Approximately 40% of HIV-infected infants in the United States in 2000 were born to women not diagnosed with their HIV prior to delivery. (1) There are now effective medical therapies to prevent perinatal transmission, including anti-retroviral therapy, but this requires diagnoses of maternal HIV prior to delivery. Both the Centers for Disease Control and Prevention (CDC) and Institute of Medicine (IOM) have published strong recommendations for universal HIV-antibody testing of pregnant women.

This will be a randomized controlled, non-inferiority trial comparing two HIV testing strategies among English and Spanish-speaking patients presenting for prenatal care at SFGH WHC over the course of approximately one year. Eligible participants will be randomized by study personnel to either standard HIV counseling and testing (control arm) or abbreviated counseling and testing (study arm). Participants will receive a standard prenatal HIV testing brochure, undergo one of two HIV counseling/testing strategies, submit blood for an HIV-1 antibody test, and will follow-up with their medical provider for HIV test results. Upon completion of counseling, participants will undergo a short, structured (Pre-test) questionnaire administered by study staff. Following testing and receipt of results, participants will complete a second (Post-test) structured questionnaire administered by study staff.

Eligible women presenting to SFGH physician or midwife prenatal clinics will be recruited, consented and randomized by study staff to either the standard or abbreviated testing strategy. The outcomes studied will be patient satisfaction and the proportion of study participants who undergo HIV testing. Potential confounder variables to be measured will include demographic characteristics, prior HIV testing history, knowledge about HIV/AIDS, attitudes towards HIV testing, HIV test result, and type of provider (physician versus midwife).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV Infections
  • Pregnancy Related
Intervention  ICMJE Procedure: Abbreviated HIV test counseling
abbreviated HIV pre-test counseling
Other Name: opt-out HIV testing
Study Arms  ICMJE
  • Experimental: Abbreviated Consenting
    Intervention: Procedure: Abbreviated HIV test counseling
  • No Intervention: Standard Consenting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2011)
281
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2007)
278
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women 16 years of age or above seeking prenatal care at San Francisco General Hospital

Exclusion Criteria:

  • Women who do not speak Spanish or English
  • Women younger than 16 years of age
  • Women who obtained an HIV test during the index pregnancy prior to initiation of prenatal care at SFGH
  • Women known to be infected with HIV at initiation of prenatal care at SFGH
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00503308
Other Study ID Numbers  ICMJE 2004-0319
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deborah Cohan, UCSF
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Deborah Cohan, MDUniversity of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP